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Bivalirudin anticoagulation in neonates and infants undergoing cardiac surgery
Suruchi Hasija1, Milind P Hote2, Neeti Makhija1
1Department of Cardiac Anesthesia and Critical Care, seventh floor, Cardiothoracic Centre, All India Institute of Medical Sciences, New Delhi 110029, India.
Insights
Bivalirudin effectively anticoagulated neonates and infants during cardiac surgery, with a mean dose of 1 mg/kg bolus and 2.2 mg/kg/h infusion. Further trials are needed to confirm safety in complex congenital heart disease.
Area of Science:
- Pediatric Cardiology
- Cardiovascular Surgery
- Pharmacology
Background:
- Congenital heart disease (CHD) necessitates complex cardiac surgeries in neonates and infants.
- Anticoagulation is critical during cardiopulmonary bypass, but optimal agents for this population are debated.
- Bivalirudin is a direct thrombin inhibitor with potential utility in pediatric cardiac surgery.
Purpose of the Study:
- To determine the effective dosage of bivalirudin for anticoagulation in neonates and infants undergoing cardiac surgery.
- To assess the safety and efficacy of bivalirudin in this specific pediatric population.
Main Methods:
- A pilot study was conducted in a tertiary-care hospital.
- Twenty-five neonates and infants with CHD received a bivalirudin bolus (1 mg/kg) followed by an infusion (initially 2.5 mg/kg/h).
- Dosage was adjusted to maintain activated clotting time (ACT) >480 seconds; ROTEM was used for baseline coagulation assessment.
Main Results:
- The required bivalirudin dose was 1 mg/kg bolus followed by a 2.2 ± 0.4 mg/kg/h infusion.
- Effective anticoagulation was achieved, with ACT >480 s maintained.
- Four children experienced excessive bleeding, and one required re-exploration; platelet counts remained low for 5 days post-surgery.
Conclusions:
- Bivalirudin can achieve effective anticoagulation in neonates and infants undergoing cardiac surgery.
- The established dosage regimen requires further investigation in larger, randomized controlled trials.
- Safety and efficacy in infants with complex CHD require additional evaluation, particularly regarding bleeding risk.
Objectives:
To determine the dosage of bivalirudin as the anticoagulant for cardiac surgery in neonates and infants.
Design:
Pilot study.
Setting:
Tertiary-care hospital.
Participants:
Twenty-five neonates and infants with congenital heart disease (CHD) undergoing cardiac surgery.
Interventions:
The children received a 1 mg/kg bivalirudin bolus followed by a 2.5 mg/kg/h infusion as the anticoagulant for cardiac surgery. The dose was adjusted subsequently to maintain an activated clotting time (ACT) >480 s.
Measurements And Main Results:
The mean age and weight were 5.3 months and 5.2 kg, respectively. Out of the 25 children, 16 were cyanotic. Baseline rotational thromboelastometry (ROTEM) (Tem Innovations GmbH, Munich, Germany) analysis revealed an underlying coagulation defect across EXTEM, INTEM, FIBTEM, and ADPTEM parameters. The dose of anticoagulant required was 1 mg/kg, followed by a 2.2 ± 0.4 mg/kg/h infusion. Only 1 child required an additional bolus dose. The ACT remained elevated for 4 hours after discontinuation of infusion. The mean 24-h postoperative chest tube drainage was 92 ± 36 mL. Excessive bleeding occurred in 4 children, 1 of whom required re-exploration. The platelet count remained low for 5 days, and, postoperatively, the prothrombin time and activated partial thromboplastin time remained low for 2 days.
Conclusions:
Effective anticoagulation was achieved with bivalirudin in the neonates and infants undergoing cardiac surgery. The dose required to maintain an ACT >480 s was 1.0 mg/kg, followed by 2.2 ± 0.4 mg/kg/h. The ACT remained elevated for 4 h after the discontinuation of bivalirudin infusion, resulting in an increased chest-tube output in some patients. Randomized, controlled trials are needed to further evaluate the safety of bivalirudin in the neonates and infants with complex congenital heart disease undergoing cardiac surgery with cardiopulmonary bypass.
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